Pegylation of recombinant blood coagulation factors in the...

A - Human Necessities – 61 – K

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A61K 47/48 (2006.01)

Patent

CA 2738064

The present invention relates to a proteinaceous construct comprising a blood coagulation factor, e.g., Factor VIII (FVIII), being bound to at least one water soluble polymer, including a poly(alkylene oxide) such as polyethylene glycol (PEG). Further the present invention relates to methods of preparing PEGylated blood coagulation factor, e.g., FVIII, in the presence of bound antibodies. The invention also relates to methods for prolonging the in vivo-half-life of blood coagulation factor, e.g., FVI-II, in the blood of a mammal having a bleeding disorder associated with functional defects or deficiencies of blood coagulation factor, e.g., FVIII.

La présente invention concerne une construction protéique comprenant un facteur de coagulation sanguine, par exemple le facteur VIII (FVIII), lié à au moins un polymère hydrosoluble, notamment un poly(oxyde dalkylène) tel quun polyéthylène glycol (PEG). En outre, la présente invention concerne des procédés de préparation de facteur de coagulation sanguine pégylé, par exemple FVIII, en présence danticorps liés. Linvention concerne également des procédés permettant de prolonger la demi-vie in vivo de facteur de coagulation sanguine, par exemple FVIII, dans le sang dun mammifère présentant un trouble hémostatique associé à des anomalies fonctionnelles ou des déficiences de facteur de coagulation sanguine, par exemple FVIII.

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